Sterility Assurance and Aseptic Processes Expert

ProductLife Group; France; Sur place; EUR 60 000 - 100 000; Plein temps

Résumé du poste

A consulting firm specializing in life sciences is seeking a Sterility Assurance and Aseptic Processes Expert in France. The role involves leading sterility assurance strategies, performing risk analyses, drafting scientific documents, and supporting regulatory inspections. Candidates should have 5-7 years of relevant experience (or 10+ for experts) and be fluent in French and English.

Qualifications

• 5-7 years of experience for confirmed or 10+ years for expert level.
• Experience in sterile operations and risk management.
• Fluency in French and English.

Responsabilités

• Lead sterility assurance strategy and implementation.
• Conduct risk analyses and execute CAPA follow-up.
• Support for regulatory inspections and documentation.

Connaissances

GMP Annex 1

Aseptic filling under isolator

Risk management

Regulatory knowledge (EMA, FDA)

Description du poste

Sterility Assurance and Aseptic Processes Expert

PLG is a consulting firm specializing in life sciences. We support our clients in their regulatory, quality, and industrial projects, providing them with expertise, agility, and commitment.

We are looking for: Sterility Assurance & Aseptic Processes Expert (Injectables)

Role / Mission

• Lead sterility assurance strategy and CCS/APS implementation.
• Risk analyses (initiation, execution, CAPA follow-up).
• Drafting of scientific justifications, protocols, reports, SOPs.
• Gap analysis vs. GMP Annex 1 & 13.
• Support for regulatory inspections and CCS documentation.

Experience level: Confirmed (5–7 years) or Expert (10+ years).

Technical Skills

• GMP Annex 1, sterile operations, aseptic filling under isolator.
• Risk management (AMDEC, deviation, change control).
• Strong regulatory knowledge (EMA, FDA).

Soft skills: Rigorous, organized, autonomous, analytical, strong relationship skills.

Practical Aspects

• Mobility across France is ideal; flexibility is possible in large industrial hubs.
• Languages: French and English are mandatory.

PLG is an equal opportunities employer and welcomes applications from diverse candidates.